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Biosense Webster, Inc. partners with leading physicians globally to conduct clinical studies to evaluate novel technologies for the treatment of complex heart rhythms and conditions.
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)
Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the IRE system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins in treatment of participants with paroxysmal atrial fibrillation.
The VARIPULSE™ Catheter and TRUPULSE™ Generator are not cleared/approved by the US FDA and are not available for sale in the US.
An Observational Post-Marketing Study Using Commercially Approved Biosense Webster, Inc. (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Design and objective: Prospective, multi-center, observational, post-marketing study to assess acute and long-term safety and performance during routine-use standard cardiac arrhythmia ablation procedures while using commercially approved Biosense Webster, Inc. medical devices.
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFICIENCY)
Design and objective: Prospective, multi-center, non-randomized, pre-market clinical evaluation to demonstrate the safety and 12-month effectiveness of the QDOT MICRO™ Catheter compared with a historical control performance goal in subjects undergoing electrophysiology mapping and radiofrequency ablation for treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation.
The QDOT™ Micro Catheter is not cleared/approved by the US FDA and is not available for sale in the US.
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR).
Design and objective: Prospective, multi-center, single-arm study to determine the safety and 12-month effectiveness of the HELIOSTAR™ Balloon Ablation Catheter for the treatment of drug-refractory paroxysmal atrial fibrillation.
HELIOSTAR™ Balloon Ablation Catheter is not cleared/approved by the US FDA and is not available for sale in the US.
WaveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2 (WAVECREST2)
Design and objective: Prospective, multi-center, randomized, active control, non-inferiority study of the Coherex WaveCrest™ Left Atrial Appendage (LAA) Occlusion System compared to the Watchman® LAA Occlusion System to evaluate the reduction in risk of ischemic stroke or systemic embolism in subjects with non-valvular atrial fibrillation who seek a non-pharmacologic alternative to chronic oral anticoagulation.
The WaveCrest™ LAA Occlusion System is not cleared/approved by the US FDA and is not available for sale in the US.
The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. Do not use the Tag Index values generated from the VISITAG SURPOINT® EPU to guide RF energy delivery. Equivalent Tag Index values do not represent equivalent RF lesion size. The clinical utility of the Tag Index value has not been established. The Tag Index values should not be used to replace standard handling precautions or other clinically accepted endpoints for RF applications such as reduction of IC signals, impedance drop, and duration. All safety considerations, cautions, and warnings that apply to the general use of the CARTO® 3 System also apply while using this module. Users should follow the instructions for use of the compatible ablation catheters (ie, THERMOCOOL SMARTTOUCH® Catheter and THERMOCOOL SMARTTOUCH® SF Catheter) to select ablation settings for an ablation procedure.
In the US, THERMOCOOL® Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR™ RMT THERMOCOOL™ Catheter).
The THERMOCOOL SMARTOUCH® SF Catheter is indicated for drug refractory recurrent symptomatic persistent atrial fibrillation (AF) (continuous AF >7 days but <1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
© Biosense Webster, Inc. 2021